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Pleura-Guard

by LiNA Medical AG

Ref 8161

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number05708265015368 UDI-DI Date3 Apr 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number57082653005-1SRJ Basic UDI-DI 05708265015368UDI-DIDate24 Feb 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic Name
Wearable percutaneous catheter/tube holder, single-use
Model / Reference
8161
Primary DI / UDI-DI
05708265015368
Basic UDI-DI
57082653005-1SRJ
FDA Product Code
KGZ
EMDN Code
M04010299 Fixing dressings - other
GMDN Term
Wearable percutaneous catheter/tube holder, single-use
Device Class
Class I
Regulation Number
878.4200
EU market of registration
Denmark
GUDID distribution status
In Commercial Distribution

Manufacturer details

EUDAMED SRN
CH-MF-000046832
Authorised representative
LiNA Medical Polska Sp. z o.o. PL-AR-000039364

Other devices from LiNA Medical AG

See all devices from LiNA Medical AG →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (17)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No